Device Classification Name |
Tampon, Menstrual, Unscented
|
510(k) Number |
K883867 |
Device Name |
CERVICAL BIOPSY INSTRUMENT |
Applicant |
MEND TECHNOLOGIES, INC. |
5757 ALPHA RD. |
SUITE 304 |
DALLAS,
TX
75240
|
|
Applicant Contact |
T. H PARKE |
Correspondent |
MEND TECHNOLOGIES, INC. |
5757 ALPHA RD. |
SUITE 304 |
DALLAS,
TX
75240
|
|
Correspondent Contact |
T. H PARKE |
Regulation Number | 884.5470
|
Classification Product Code |
|
Date Received | 09/13/1988 |
Decision Date | 11/29/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|